FDA 483 - Compound Preferred LLC - December 17, 2021

This FDA Form 483 was issued to Compound Preferred LLC, an outsourcing facility located at 1125 Hollipark Dr., Idaho Falls, ID 83401, following an inspection from November 9 to December 17, 2021. Robert A. Myers, Operations Manager, was the recipient.

The inspection revealed seven observations:

1. **Inadequate Product Evaluation and Remedial Action for Microbial Contamination:** The firm failed to adequately investigate and address actionable microbial contamination in ISO 5 and ISO 7 classified areas. This included: * Inadequate root cause analysis and corrective actions for 13 personnel monitoring excursions (9 involving spore-forming microorganisms), with the Quality Unit relaxing action limits instead of addressing root causes. * Failure to isolate or identify colonies from personnel gown excursions, and releasing compounded drugs for distribution. * Compounding technicians discarding plates with microbial growth without notifying the Quality Unit, leading to delayed non-conformance initiation and release of affected lots (e.g., Procaine 1%). * Inadequate root cause analysis and corrective actions for eight non-viable particulate excursions in ISO 5/7 areas, with the Quality Unit changing SOPs to reflect averaging of results. * Failure to open non-conformances or conduct investigations for two additional non-viable particulate excursions. This is a repeat observation from August 2019.